Cell and gene therapies (CGT) present interesting challenges for E&L testing, for several reasons. With CGT, the manufacturing process is, in fact, the drug. Compared to conventional biopharmaceutical drugs products, the ratio of the surface area of the contact materials to the drug volume is very high. Since the process is unique for each patient, in that the patient receives the entire dose of product and leachables, each treatment is a de facto “lot release” event.
As a result of these dynamics, the initial materials/risk assessment is an especially important step for CGT products, and partnering with an E&L expert team with CGT experience is essential to designing a study that will satisfy regulatory review.
The earlier a CGT company qualifies its process for E&L, the more efficiently it will be able to commercialize. Whereas a traditional drug developer will often qualify its products for E&L during phase 3 or even post-approval, CGT developers can benefit from qualifying their processes in earlier stage clinical development.
This is due to the accelerated approvals that are often available for CGT products when efficacy is demonstrated, and can also be motivated by a desire to ensure that cell growth and transitions are not being adversely affected by toxicity from leachable compounds.
We have performed risk assessments, gap analyses and extractables and leachable testing for several CGT products. Given our partnership approach and deep understanding of the E&L regulatory landscape, along with our industry collaborations and independent research, VR Analytical is well positioned to support your CGT qualification program.
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